Binax, Inc. - FDA 510(k) Cleared Devices
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Binax, Inc. Microbiology ✕
21 devices
Cleared
Apr 14, 2010
BINAXNOW PBP2A TEST, MODEL 890-000
Microbiology
432d
Cleared
Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
Microbiology
252d
Cleared
Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
Microbiology
254d
Cleared
Sep 04, 2009
CLEARVIEW ADVANCED STREP A , MODEL 737-430
Microbiology
107d
Cleared
Sep 01, 2009
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
Microbiology
259d
Cleared
Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
Microbiology
20d
Cleared
Nov 09, 2006
BINAXNOW INFLUENZA A & B TEST
Microbiology
108d
Cleared
Nov 30, 2005
BINAXNOW INFLUENZA A & B TEST
Microbiology
23d
Cleared
Aug 10, 2004
BINAXNOW INFLUENZA A & B TEST
Microbiology
110d
Cleared
Oct 21, 2003
BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY...
Microbiology
97d
Cleared
Sep 19, 2002
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
Microbiology
122d
Cleared
Sep 19, 2002
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
Microbiology
122d
Cleared
Sep 13, 2002
BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN...
Microbiology
114d
Cleared
Nov 30, 2001
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
Microbiology
116d
Cleared
Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
Microbiology
21d
Cleared
Aug 27, 1999
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12...
Microbiology
99d
Cleared
Aug 21, 1998
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG...
Microbiology
57d
Cleared
Mar 22, 1996
BINAX STREP A TEST
Microbiology
30d
Cleared
Sep 20, 1994
BINAX LEGIONELLA URINARY ANTIGEN EIA
Microbiology
340d
Cleared
Nov 20, 1987
BINAX EQUATE STREP B
Microbiology
119d
Cleared
Dec 22, 1986
BINAX STREP A
Microbiology
76d